BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYREX PREFILLED SALINE SYRINGE 2.5CC

    MDR report key: 283817 · Received June 27, 2000

    Report

    Report Number
    MW1019192
    Event Type
    Malfunction
    Date Received
    June 27, 2000
    Report Date
    June 26, 2000
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER OPENED THE PACKAGING OF A PRE-FILLED SALINE SYRINGE AND FOUND A DEAD INSECT IN THE TUBE BARREL. SUPPLY PERSONNEL ALSO DID A VISUAL INSPECTION ON MATERIAL AND FOUND SPECKS OF DIRT IN VARIOUS SYRINGES. REPORTED ON 0.5CC SALINE SYRINGE THAT A DEAD INSECT WAS FOUND IN THE TUBE BARREL. SUPPLY PERSONNEL CONDUCTED A VISUAL INSPECTION ON ALL SIZES OF THE SALINE SYRINGES AND FOUND SPECKS OF DIRT IN BOTH SIZES 0.5CC AND 2.5CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYREX PREFILLED SALINE SYRINGE 2.5CC PREFILLED SALINE SYRINGE FPA EXCELSIOR MEDICAL CORP. S3 10/16/01, 12/01/01, (MORE)
    2 SYREX PREFILLED SALINE SYRINGE 0.5 CC PREFILLED SALINE SYRINGE FPA EXCELSIOR MEDICAL CORP. S5 12/02/01, 03/02/01

    Patients

    Seq Age Sex Outcome Treatment
    1 *